Regional Clinical Supply Pharmacist

hace 6 meses

Buenos Aires, Argentina Pfizer A tiempo completo

Why Patients Need You

The Regional Clinical Supply Pharmacist is responsible for developing, coordinating, and executing the clinical supply strategy across Latin America (LATAM) region for local and global studies involving clinical sites including Investigational Product (IP) supply, logistics, and training.

This role will have multiple responsibilities and collaborations across main Global Clinical Supply (GCS) functional lines as Clinical Research Pharmacy (CRP), Clinical Supply Strategy & Management (CSSM), Clinical Supply Operations (CSO), and Innovative Sciences Operations (ISO).

How You Will Achieve It- Support clinical supply strategic plans for clinical trials and Early Access programs conducted in the region to ensure timely delivery and resource optimization.- Provide local support for Pfizer Regulatory Affairs, Global Product Development (GPD) and external partners (CRO) in Clinical Trial Application (CTA) by being accountable for reviewing IP related documentations (drug supply description, forecast, manufacture information, etc) for quality and compliance purposes before MoH submission.- Assist Pfizer Regulatory Affairs and/or external partners (CRO) with Import License umbrella review and validation (drug supply forecast) for quality and compliance purposes, whenever needed.- Clarify countries nuances, requirements, timelines, costs to global and local partners/vendors to facilitate trials conduction in the region.- Anticipate any risks or issues associated with clinical supplies strategies across the region.- Support regional clinical supply demand and forecast based on protocols design.- Provide regional and local clinical pharmacy expertise in the development and management of investigational product handling manuals/pharmacy manuals for utilization by clinical sites.- Educate local clinical site personnel through in-services, investigator meetings and clinical site initiations or follow-up visits on the proper handling and use of investigational products, when necessary.- Support Clinical Research Pharmacy strategy across Latin America region.- Provide consultation to regional clinical project teams on medication/device related issues, such as concomitant medications, exclusionary medications, and patient compliance/adherence issues.- Represent the GCS LATAM team in global projects and initiatives to provide broader perspectives and backgrounds, in addition to add diversity into discussions (e.g., Sustainability, DE&I, Digital Clinical Supply Chain, Innovation Lab, etc).- Conducting clinical supply import/export processes in Argentina and supporting import/export processes across LATAM countries, as needed.- Serve as a point of contact between the GCS functional lines and strategic vendors such as brokers, carriers, warehouse, storage, and domestic distribution providers to ensure safe and secure movement of clinical supplies to patients.

BASIC QUALIFICATIONS- Pharmacy degree (or equivalent) is required, with 3 to 5 years minimum of relevant experience (hospital or pharmaceutical industries preferred).- Previous experience with clinical supply importation process and/or commercial importation process in Argentina.- Work experience must include some of the following: drug development, clinical study design, scientific research, pharmaceutical manufacturing / packaging / labeling, cGMP requirements, leading project teams.- Ability to speak major languages (English and Spanish) in the region to communicate with local authorities & partners, and read local documents related to clinical supplies.

PREFERRED QUALIFICATIONS- Clinical Research Experience (i.e., CRA/Monitoring, regulatory, clinical supply chain) preferred.

TRAVEL- Ability to travel (domestic and international) up to 10% of the time; must be able to drive and/or fly to vendor locations with advance notice and/ or attend job related training, as required.- Occasional travel to Pfizer, clinical sites, and vendor sites may be required.

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

EEO (Equal Employment Opportunity) & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national

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